- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02076724
Reinforcement of the Abdominal Wall After Breast Reconstruction With the Pedicled TRAM-flap
Reinforcement of the Abdominal Wall With Acellular Dermal Matrix (Strattice™) After Breast Reconstruction With the Pedicled TRAM-flap
The purpose of this study is to compare two methods for reinforcement of the abdominal donor-site after breast reconstruction with the pedicled TRAM-flap. Reinforcement of the abdominal donor-site is performed, after randomization, with either a porcine derived biological mesh or a synthetic mesh. The patient and the investigator is blinded.
The aim is to identify the most optimal method for reinforcement of the abdominal donor-site and thereby contribute to fast and complete rehabilitation of women undergoing breast reconstruction with the pedicled TRAM-flap after surgical removal of the breast tissue due to breast cancer, precursors to breast cancer or an increased risk of developing breast cancer and thereby following preventive removal of the breast tissue.
The patients visit the outpatient clinic 4, 12 and 24 months after operation and abdominal wall function, the donor site morbidity, the frequency of postoperative complications, the aesthetic appearance of the reconstructed breast and the abdominal wall and costs are evaluated.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aarhus
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Aarhus C., Aarhus, Denmark, 8000
- Department of Plastic and Reconstructive Surgery, Aarhus University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Immediate or delayed breast reconstruction using the pedicled TRAM-flap
- Older than 18 years of age
- Understand enough Danish to comprehend the given information and to complete the study questionnaire
- Verbal and written informed consent
Exclusion Criteria:
- Current smokers
- Not eligible patients, assessed by surgeon
- High level of co-morbidity, assessed by surgeon or anesthesiologist
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Biological mesh (Strattice Firm)
Strattice Firm is inserted using inlay technique as reinforcement of the abdominal wall where the anterior rectus fascia has been excised.
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Other Names:
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Experimental: Synthetic mesh (Prolene)
Prolene mesh is inserted using inlay technique as reinforcement of the abdominal wall where the anterior rectus fascia has been excised.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abdominal wall function change
Time Frame: Change from before surgery to 12 and 24 months after surgery
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Strength of abdominal wall is assessed by a standardized physical examination developed in collaboration with physiotherapists.
A dynamometer is used to get an exact value of muscle strength.
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Change from before surgery to 12 and 24 months after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abdominal donor site morbidity
Time Frame: 24 months
|
Bulge
Hernia
Abdominal donor site correction procedure (within 24 months) Pain/ discomfort
|
24 months
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Aesthetics at the abdominal wall
Time Frame: 24 months
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Study specific questionnaire regarding postoperative assessment of the outcome including:
Investigators assessment of the abdominal donor site including:
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24 months
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Costs
Time Frame: 24 months
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National health insurance rate Cost of Strattice (LifeCell), Prolene mesh (Ethicon) Operation time Hospitalization Time to return to work / Duration of sick leave Post-reconstruction procedures to address complications at the abdominal donor site.
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24 months
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Postoperative complications
Time Frame: Acute <1 month, ≥ 1 month-24 months
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Hematoma requiring surgical intervention. Cellulitis/ wound infection not requiring surgical intervention but treatment with antibiotics. Infection requiring surgical intervention. Seroma requiring intervention Donor site necrosis (present necrosis - excluding epidermolysis, in the umbilical area or in the remaining abdominal skin and subcutaneous tissue requiring surgical intervention) |
Acute <1 month, ≥ 1 month-24 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mette Eline Brunbjerg, MD, Aarhus University Hospital and Aarhus University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- VEK 1-10-72-10-13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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